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01 5ALVOGEN
02 5AMNEAL
03 7BRAEBURN
04 5DIFGEN PHARMS
05 2INDIVIOR
06 5MYLAN TECH VIATRIS
07 5PURDUE PHARMA LP
08 5WATSON LABS TEVA
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01 30FILM, EXTENDED RELEASE;TRANSDERMAL
02 9SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS
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01 6DISCN
02 33RX
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01 7BRIXADI
02 25BUPRENORPHINE
03 5BUTRANS
04 2SUBLOCADE
01 25No
02 14Yes
RLD : No
TE Code : AB
Brand Name : BUPRENORPHINE
Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL
Dosage Strength : 5MCG/HR
Approval Date : 2018-11-20
Application Number : 204937
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : BUPRENORPHINE
Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL
Dosage Strength : 10MCG/HR
Approval Date : 2018-11-20
Application Number : 204937
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : BUPRENORPHINE
Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL
Dosage Strength : 15MCG/HR
Approval Date : 2018-11-20
Application Number : 204937
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : BUPRENORPHINE
Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL
Dosage Strength : 20MCG/HR
Approval Date : 2018-11-20
Application Number : 204937
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : BUPRENORPHINE
Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL
Dosage Strength : 7.5MCG/HR
Approval Date : 2021-06-29
Application Number : 204937
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : Yes
TE Code : AB
Brand Name : BUTRANS
Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL
Dosage Strength : 5MCG/HR
Approval Date : 2010-06-30
Application Number : 21306
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : Yes
TE Code : AB
Brand Name : BUTRANS
Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL
Dosage Strength : 10MCG/HR
Approval Date : 2010-06-30
Application Number : 21306
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : Yes
TE Code : AB
Brand Name : BUTRANS
Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL
Dosage Strength : 20MCG/HR
Approval Date : 2010-06-30
Application Number : 21306
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : Yes
TE Code : AB
Brand Name : BUTRANS
Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL
Dosage Strength : 15MCG/HR
Approval Date : 2013-07-25
Application Number : 21306
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : Yes
TE Code : AB
Brand Name : BUTRANS
Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL
Dosage Strength : 7.5MCG/HR
Approval Date : 2014-06-30
Application Number : 21306
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB